Member Representatives Discussed Vaccine Management: Strengthening Vaccine R & D Input And Supporting Platform Construction

Vaccines have always been the focus of public attention. At the NPC and CPPCC sessions this year, the NPC deputies and CPPCC members also put forward relevant suggestions on R & D, investment, safety and emergency reserve. In 2020, the government's work report also mentioned that vaccine development and vaccine research and development should be strengthened.

      Qian Fang Li, director of the National People's Congress, member of the finance and Economic Committee of the National People's Congress, the Standing Committee of the Central Committee of the National People's Congress and the director of the Department of e-commerce and information technology of the Ministry of Commerce, found that China's vaccine reserve system has some problems such as weak basic vaccine research, low scale of vaccine reserve, insufficient capital investment and lack of long-term mechanism. It is suggested that the vaccine with the combination of enterprises as the main body and industry, University and Research Institute should be established. The system of R & D and industrialization should be set up to perfect the system of vaccine reserve that is compatible with China's national conditions.

      In 2020, "voice responsibility" medical and health sector NPC and CPPCC members held a symposium. Zhu Tao, chief executive of the CPPCC National Committee and chief scientific officer of Kangxi, told the media including the twenty-first Century economic correspondent, he hoped that the state would invest more in establishing the National Laboratory of emergency vaccine. Prepare the P3 workshop approval mechanism for vaccine enterprises.

Vaccines have always been the focus of public attention. - Xinhua News Agency

Strengthening technology platform construction

Zhu Tao believes that the emergency vaccine technology platform is the core force to deal with the urgent epidemic. In this type of platform, new infectious diseases vaccine can be developed quickly and achieve a certain production capacity. In general, millions or tens of millions of agents can meet local infectious disease outbreaks. Even with major infectious diseases such as new crown pneumonia, these platforms can expand in a short time and reach sufficient capacity in the shortest possible time, which will have a significant impact on disease control.

Taking the viral vector vaccine platform as an example, Zhu Tao said that the platform could form candidate vaccines within two months, such as the Ebola vaccine in 2014 and the new crown vaccine this year. Although many units have similar carrier vaccine platforms, most of them do not have the capability of large-scale production. Some of the core technologies also rely on imports, such as serum-free medium, nuclease, ultrafiltration membrane package and so on.

Zhu Tao believes that the state needs to support the development of emergency vaccine, especially the rapid response platform technology. Because these technologies and platforms sometimes do not produce direct economic benefits, and require government backing.

"The establishment of national laboratories for emergency vaccines can also be extended to biological products such as emergency antibodies. The core technology platform should be developed based on the scientific research strength of the country. At the same time, we should combine advantage enterprises to transform technology and products to get economic returns. In the limited advantage units, we can support the construction of characteristic platforms, and we can delegate R & D or expropriation in case of emergency. Zhu Tao suggested.

Qian Fang Li also suggested strengthening the development of a new vaccine development platform for infectious diseases. We should strengthen the research on applied basic technology of etiology and immunology, and build a research and development platform for yeast, Escherichia coli, CHO cells (Chinese hamster ovary cells) and insect cell expression system, and take the enterprise as the main body, and set up the national R & D Center for new emerging infectious diseases vaccine.

At the above forum, Ankang also suggested that we should strengthen the level of biosafety of the new crown vaccine and accelerate the examination and approval of the production workshop.

      Ankang told the twenty-first Century economic news reporter that there are still no P3 level laboratories and production workshops in China, and the previous studies of all enterprises are cooperating with research institutes with P3 laboratories. In the future, the production and supply of new crown vaccine must be produced in the P3 level production workshop that meets the requirements of GMP. Therefore, the trial of vaccine P3 and vaccine production workshop should be accelerated. Batch and acceptance are of great importance.

It is understood that the current number of new infectious disease high level biosafety research platform in China is small. At present, there are only 89 biological safety three-level (BSL-3) laboratories (P3) in China, of which 55 are cell research laboratories, while in other developed countries in the world, the number of biosafety laboratories is much higher than that of China. Taking the United States as an example, in 2011, there were 1495 P3 laboratories, 17 times the number of laboratories in China.

Strengthening emergency reserve

Qian Fang Li found that there are some problems in our vaccine reserve system, such as weak basic research of vaccine, low scale of vaccine reserve, variety structure and single reserve mode.

Ankang uses influenza vaccine reserve as an example. When the outbreak of H1N1 flu occurred in 2009, the state and enterprises invested a lot of money to expand the production capacity of the influenza vaccine. The government issued a vaccine production plan to 10 enterprises, including 795 batches and 150 million doses. However, after the first influenza A, the demand for influenza vaccine in China is less than 1/5 of the capacity. Contradictions should be concerned.

For this reason, Ankang proposes to consider how to compensate the R & D investment of enterprises, set up national special emergency requisition funds, improve the requisition system, and make enterprises that respond to emergency contributions to get sufficient economic protection.

Qian Fang Li suggested that the national immunization plan vaccine reserve mechanism should be established and improved, and the physical reserve for the annual demand for vaccine products currently included in the reserve plan for the regional epidemic related diseases should be established. The vaccine production capacity reserve should be implemented, and the dual production backup of the immunization plan vaccine should be implemented. Each vaccine will be produced by 2 enterprises or 2 independent workshops, and will be 150% in accordance with the annual market demand. Capacity reserves.

In addition, Qian Fang Li also suggested strengthening the construction of relevant regulations and standards system, establishing a vaccine reserve management system, making clear the organizational structure, defining the types and ways of reserves, and putting forward the strategic layout, planning, implementation path and safeguard measures. We should improve the relevant laws and regulations of reserve emergency system for vaccine research and development, production and circulation.

Zhu Tao also put forward the suggestion that we must quickly realize the new crown vaccine production capacity, under the condition of guaranteeing the quality of products, take the way of authorization, make effective use of spare capacity, and suggest that the state confirm orders or tasks as early as possible, so that manufacturers can prepare raw materials, consumables, excipients and packaging materials ahead of schedule. "The procurement and approval process should be prepared ahead of time, and the vaccine can be put into operation if approved by the central authority."

In addition to focusing on vaccine production and platform construction, NPC representatives also put forward relevant suggestions on the safety of vaccination.

In December 1st last year, the People's Republic of China vaccine management act was formally implemented. In addition to the most stringent penalties for vaccine violations, detailed provisions were also made in the aspects of vaccine development, production, circulation, vaccination and so on.

However, in the process of vaccine transportation and vaccination, there are still some problems such as poor cold chain, poor vaccination environment, opaque information, difficult problem traceability and blind area supervision. In this regard, Zhou Yunjie, President of the National People's Congress and President of Haier group, suggested that Internet of things should be applied to ensure the safety of vaccination.

"Through the Internet of things technology to solve the vaccine transport, process traceability and safety vaccination and other aspects of the short board problem, to achieve good vaccine, good vaccine, the whole process can be displayed and traceable, to provide consumers need vaccine brand, so that the public can safely and safely vaccinated." Zhou Yunjie said.

    Zhou Yunjie suggested that the national health and Health Commission should take the lead in formulating policies to promote the construction of standards for immunization clinics in all areas, upgrade the norms for the design and renovation of preventive immunization clinics, and require new immunization clinics to upgrade the existing vaccination clinics with the application of IOT based vaccination and storage facilities, and popularize mobile vaccinated vehicles in inaccessible areas. In addition, we should further enhance the safety guarantee ability of vaccination in China.

    At the same time, it is suggested that the relevant policies be formulated by the National Health Protection Commission to encourage enterprises, hospitals, CDC and other parties to participate in the project, and support the vaccination management mode based on the Internet of things technology in the more than 50000 vaccination clinics in the country. We will use the Internet of things technology to connect all the local immunization visits and connect the city vaccine network to the regional network and the national network to form a vaccine covering the whole country. The platform of safety and information technology can realize the information sharing and co-ordination management of the national vaccine, and provide guarantee for the implementation of the vaccine management law.

(author: Southern finance and Economics National two sessions report group Zhu Ping)